BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 5772824 · Received July 6, 2016

    Report

    Report Number
    3002769706-2016-00115
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Report Date
    July 1, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE (B)(6) REPORTED AN OCCURRENCE OF A FALSE POSITIVE RESULT FOR (B)(6) SPECIMEN (B)(6) IN ASSOCIATION WITH THE VIDAS MEASLES IGG ASSAY. THE EXPECTED RESULT WAS "NEGATIVE". BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE (B)(6) (DISTRIBUTION (B)(6)) REPORT INDICATES: ONE-HUNDRED THIRTY-SIX (136) PARTICIPANTS GAVE THE CORRECT ANSWER NEGATIVE. TWENTY-FIVE (25) PARTICIPANTS GAVE AN EQUIVOCAL ANSWER (24 PARTICIPANTS USING VIDAS MSG). EIGHTEEN (18) PARTICIPANTS GAVE A POSITIVE ANSWER (15 PARTICIPANTS USING VIDAS MSG). IN PRE-DISTRIBUTION TESTING, THE MEASLES IGG RESULTS WERE NEGATIVE WITH TRINITY BIOTECH, CAPTIA, SIEMENS ENZYGNOST, DIASORIN LIAISON ASSAYS AND EQUIVOCAL WITH BIOMÉRIEUX VIDAS. REVIEW OF COMPLAINT HISTORY INDICATES THAT NO OTHER COMPLAINT HAS BEEN REGISTERED FOR VIDAS MSG LOT 1004457540 / 160929-0 FOR EXTERNAL CONTROL FROM (B)(6). ANALYSIS OF THE MANUFACTURING BATCH HISTORY RECORDS SHOWED NO ANOMALY DURING THE CONTROL PROCESS. THE ANALYSIS OF THE CONTROL CHARTS FOR FIVE (5) INTERNAL (B)(6) (THREE NEGATIVE AND TWO POSITIVE) ON SIX (6) VIDAS® MSG BATCHES SHOWED THAT ALL RESULTS ARE IN THE TREND AND WITHIN SPECIFICATIONS OR ACCEPTABLE WITHOUT CHANGE OF INTERPRETATION. THE QUALITY PRODUCT LABORATORY TESTED INTERNAL (B)(6) ON THE RETAIN KIT VIDAS MSG 1004457540 / 160929-0; THE RESULTS WERE COMPLIANT WITH SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE PERFORMANCE OF VIDAS MSG LOT 1004457540 / 160929-0 IS OUTSIDE SPECIFICATION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE RESULT WITH THE VIDAS® MEASLES IGG (REFERENCE (B)(4)); A SINGLE SPECIMEN (SPECIMEN (B)(4)) WAS TESTED DURING (B)(6) QC. IN PRE-DISTRIBUTION TESTING THE MEASLES IGG RESULTS WERE NEGATIVE WITH TRINITY BIOTECH, CAPTIA, SIEMENS ENZYGNOST, DIASORIN LIAISON ASSAYS AND EQUIVOCAL WITH BIOMÉRIEUX VIDAS®. BASED ON THE INFORMATION PROVIDED THERE WAS NO ADVERSE EVENTS, NEGATIVE PATIENT IMPACT OR DELAY IN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425575 VIDAS® MEASLES IGG VIDAS® MEASLES IGG LJB BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1